Catheter anchoring system

ABSTRACT

A catheter anchoring system is provided to securely anchor to a patient&#39;s skin a catheter and fluid supply tube interconnection. The anchoring system comprises a retainer configured to receive a catheter adaptor in a variety of positions. The adaptor interconnects the catheter and the fluid supply tube. In one embodiment the adaptor has a radial recess that circumscribes the adaptor. The anchoring system additionally includes a flexible, adhesive anchor pad which can supports a tube clip, as well as the retainer. The retainer includes a channel that is configured to receive the adaptor in a snap-fit manner. The retainer also includes a plurality of laterally arranged projections that extend from a channel wall and into a channel. Each radial recess is sized to receive and to capture at least a portion of the projection of the retainer so as to inhibit the adaptor from moving within the channel.

RELATED CASES

This is a continuation application of application Ser. No. 10/096,088filed 11 Mar. 2002 now U.S. Pat. No. 6,827,705, which is acontinuation-in-part of application Ser. No. 09/809,460 filed 15 Mar.2001, now U.S. Pat. No. 6,786,892 issued on 7 Sep. 2004, which is acontinuation of application Ser. No. 09/069,029 filed 27 Apr. 1998, nowU.S. Pat. No. 6,290,676 issued on 18 Sep. 2001, which is acontinuation-in-part of application Ser. No. 08/753,277 filed 25 Nov.1996, now U.S. Pat. No. 5,827,230 issued on 27 Oct. 1998, which is acontinuation of application Ser. No. 08/223,948 filed 6 Apr. 1994, nowU.S. Pat. No. 5,578,013 issued 26 Nov. 1996, which is acontinuation-in-part of application Ser. No. 08/121,942, filed 15 Sep.1993, now U.S. Pat. No. 5,456,671 issued 10 Oct. 1995, which is acontinuation-in-part of application Ser. No. 08/034,340 filed 19 Mar.1993, now U.S. Pat. No. 5,354,282 issued 11 Oct. 1994, all of which arehereby incorporated by reference in their entireties. This applicationis a continuation application of copending application Ser. No.10/096,088 filed 11 Mar. 2002, which is also a continuation ofapplication Ser. No. 09/165,367 filed 2 Oct. 1998 now U.S. Pat. No.6,837,875, which is a continuation-in-part of application Ser. No.09/069,029 filed 27 Apr. 1998, now U.S. Pat. No. 6,290,676 issued on 18Sep. 2001 and whose predecessor cases are listed above, all of which arehereby incorporated by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in general to a percutaneouscatheterization system, and, in particular, to a catheter anchoringsystem which securely interconnects an indwelling catheter with a tubingand securely anchors such interconnection to a patient's skin.

2. Description of Related Art

Medical treatment of patients commonly involves the use ofpercutaneously inserted catheters to direct fluids directly into thebloodstream, a specific organ or an internal location of the patient, orto monitor vital functions of the patient. For instance,intra-arteriosus catheters are commonly used to direct fluids and/ormedication directly into the bloodstream of the patient. Epiduralcatheters are commonly used to direct anesthesia into an epidural spaceto anesthetize a specific location of the patient. Intervascularcatheters are commonly used to monitor arterial blood pressure.

The fluid (e.g., parenteral liquid, medication or anesthesia) typicallydrains from a container positioned above the patient. The fluid flowsthrough tubing and into an indwelling catheter. The catheter and fluidtubing are commonly removably attached by a conventional lure-typeconnector, such as the type described in U.S. Pat. No. 4,224,937.

In common practice, a health care provider, such as, for example, anurse or doctor (for ease of description, as used herein the term“nurse” will refer to health care providers generally and will not berestrictive in meaning), uses adhesive or surgical tape to maintain thecatheter in place on the skin of the patient. The connection between thetubing and the catheter is likewise maintained by use of tape.

The nurse may also form a safety loop in the tubing so that any tensionapplied to the tubing does not directly pass to the catheter cannula,but rather is absorbed by the slack of the safety loop. The nursetypically loosely tapes the loop to the skin of the patient.

This entire taping procedure takes several minutes of the valuable timeof the health care provider. Furthermore, nurses commonly remove theirgloves when taping because most nurse find such taping proceduresdifficult and cumbersome when wearing gloves.

The catheterization process often requires frequent disconnectionbetween the catheter and the fluid supply tube. For instance,intravenous catheterization is frequently maintained for several days,depending upon the condition of the patient. The catheter tubing isgenerally replaced every 24 to 48 hours in order to maintain thesterility of the fluid and the free-flow of the fluid through thetubing. A nurse must thus frequently change the tubing and retape theconnection. Moreover, the tape, which secures the catheter to the skinof the patient, often covers the cannula insertion point. The nurse mustremove the tape to inspect the insertion point for inflammation orinfection, and must then repeat the above-described taping procedure.

A great deal of valuable time is thus used in applying significantamounts of surgical tape to indwelling catheters. The frequentapplication and removal of surgical tape also commonly results in theexcoriation of the skin of the patient in the area of the insertion.

A number of catheterization systems have recently been developed whichimprove the stabilization of the catheter system and obviate the needfor frequent application and removal of surgical tape. One such systemis disclosed by U.S. Pat. No. 5,192,273 issued to the present Applicant,which is hereby incorporated by reference.

The '273 patent discloses an adaptor which interconnects the catheterwith a fluid supply tubing. The adaptor snaps into a base attached tothe patient's skin by an adhesive pad. Specifically, a nurse presses theadaptor between upstanding legs of the base. Detents on the adaptor legsslide into corresponding annular grooves in the adaptor body to hold theadaptor to the base.

Although the base holds the adaptor securely in place, a nurse may havedifficulty positioning and aligning the annular grooves of the adaptorwith the detents on the base. Exigent circumstances may furtherexacerbate the difficulties associated with properly positioning theadaptor onto the base. Some nurses and other health care providers mayalso have trouble determining how to engage the catheter adaptor withthe base.

SUMMARY OF THE INVENTION

The catheter anchoring system of the present invention provides anadaptor retainer which is not position or technique sensitive. That is,the nurse simply locates the catheter adaptor generally above theretainer, and presses the adaptor into the retainer. Engagement requiresonly coarse alignment of the adaptor with the retainer.

In accordance with one aspect of the present invention, an anchoringsystem is provided for use with a catheter having an adaptor with atleast one recess. A retainer is provided to receive the adaptor. Theretainer includes a channel that extends through the retainer about alongitudinal axis. The channel is configured to receive at least aportion of the adaptor in a snap-fit manner. At least one projection onthe retainer extends into the channel in a direction generally normal tothe longitudinal axis. The projection has a longitudinal length sodimensioned to substantially equal the longitudinal length of the recessof the adaptor. The cooperation between the projection of the retainerand the recess of the adaptor inhibit longitudinal movement of theadaptor relative to the retainer.

In accordance with another aspect of the present invention, an anchoringsystem is provided for use with a catheter having an adaptor with arecess. The retainer includes a channel that extends through theretainer about a longitudinal axis. The channel is configured to receiveat least a portion of the adaptor in a snap-fit manner. At least oneprojection on the retainer extends into the channel in a directiongenerally normal to the longitudinal axis. The projection has alongitudinal length so dimensioned to substantially equal thelongitudinal length of the recess of the adaptor. The cooperationbetween the projection of the retainer and the recess of the adaptorinhibit longitudinal movement of the adaptor relative to the retainer.

In accordance with yet another aspect of the present invention, ananchoring system is provided for use with a catheter having an adaptorwith a radially extending member that projects from the fitting. Theanchoring system comprises a retainer that includes first and secondchannel portions. The channel portions extend about a longitudinal axis,and each is configured to receive a corresponding portion of thecatheter fitting. A plurality of lateral slots are positioned betweenthe channel portions. Each lateral slot is dimensioned so as to receivethe radially extending member of the catheter fitting to prevent thecatheter from moving in a longitudinal direction. The lateral slots arealso arranged next to each other along the longitudinal axis so as toprovide multiple positions in the longitudinal direction in which toinsert the radially extending member of the catheter fitting whenpositioning the catheter fitting within the retainer.

Another aspect of the present invention involves a catheterizationsystem includes a catheter and a retainer to secure the catheter to apatient. The catheter includes a fitting with a radially extendingmember that projects from the fitting. The retainer includes first andsecond channel portions that extend about a longitudinal axis. Eachchannel portion generally has a truncated cross-sectional shape with anopening along the longitudinal axis. Each channel is also sized tosurround at least a portion of the fitting through an arc of greaterthan 180° about the longitudinal axis. At least one lateral slot of theretainer extends generally perpendicular to the longitudinal axis andlies between the first and second channel portions. The slot has alongitudinal length so dimensioned to substantially equal the thicknessof the radially extending member of catheter fitting and to be generallyless than the combined longitudinal lengths of the first and secondchannel portions. This dimensional relationship between the channelportions and the slot provides lateral stability of the catheter fittingwhen the radially extending member is positioned within the lateral slotof the retainer.

In accordance with a further aspect of the present invention, a catheteranchoring system comprises a catheter adaptor, a retainer and a base padwhich adheres to the skin of a patient and supports the retainer. Thecatheter adaptor comprises a tubular body connected to a radiallyextending support arm. The support arm in turn connects to a clip whichpivots relative to the tubular body.

The retainer comprises a pair of opposing longitudinal walls. Each walldefines a series of slots. Each slot is sized such that a portion of thesupport arm of the catheter adaptor extends through the slot. The slotprevents the support arm from moving in a direction generally parallelto a longitudinal direction of the retainer.

The retainer further comprises a central channel which extends throughthe retainer about an axis which is generally parallel to thelongitudinal axis. The channel is interposed between the opposinglongitudinal walls and has a truncated circular cross-sectional shape.The central channel, in cross-section, is sized to encompass the tubularbody through an angle greater than about 180N.

The anchoring system may additionally comprise a tube clip configured toreceive a portion of the tube. The anchoring system may also comprise anS-clip having a plurality of retainers to secure a microbore tubingconnected to the tube by the adaptor.

An additional aspect of the present invention provides a catheteranchoring system for securing an indwelling catheter within a body lumenof a patient and for securely interconnecting the indwelling catheterwith a tube. The catheter anchoring system comprises a catheter adapterhaving a generally tubular body defined between distal and proximalends. The distal end is configured to engage the catheter proximal endand the proximal end is configured to couple to a distal end of thesupply tube. The catheter adapter additionally comprises a radiallyextending member which projects from an exterior surface of the tubularbody in a radial direction.

A retainer of the catheter anchoring system comprises a longitudinalchannel configured to receive the tubular body of the adapter in a snapfit manner. The retainer additionally comprises a plurality of lateralslots or projections which are sized to receive and to capture theradially extending member of the adapter with the adapter positionedwithin the channel. The slots can be formed in a variety of ways, suchas by laterally arranging a plurality of gaps next to each other andthrough the opposing longitudinal walls of the retainer. The projectionscan similarly be formed in a variety of ways, such as by laterallyarranging a plurality of projections next to each other from theopposing longitudinal walls of the retainer and projecting theprojections into the channel. The retainer prevents the adapter fromsliding in a longitudinal direction when one of the slots.

In a preferred embodiment, the radially extending member comprises asupport arm which connects a clip to the tubular body. In an alternativepreferred embodiment, the radially extending member comprises an annularcollar which circumscribes the tubular body.

In accordance with a preferred method of anchoring an indwellingcatheter/tube interconnection to a patient, an adapter is providedhaving a generally tubular body with a recess. An anchor pad is alsoprovided with an adhesive back. The anchor pad supports a retainerconfigured to receive the adapter and has a series of lateralprojections. The anchor pad is attached to the patient's skin proximateto an indwelling catheter. The recess of the adapter is positioned abovethe series of projections. The retainer is deflected so as to open thechannel to a size sufficient to receive the adapter, and the adapter isinserted into the channel. The recess is inserted around at least aportion of one of the projections. The retainer is then permitted tospring back to an undeflected position such that the tubular body iscaptured within the retainer.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features of the invention will now be described withreference to the drawings of preferred embodiments which are intended toillustrate and not to limit the invention, and in which:

FIG. 1 is a perspective view of a catheter anchoring system inaccordance with a preferred embodiment of the present invention, mountedon the back of a patient's hand;

FIG. 2 is a top plan view of the catheter anchoring system of FIG. 1;

FIG. 3 is a top plan view of a retainer of the catheter anchoring systemof FIG. 2;

FIG. 4 a is a front elevational view of the retainer of FIG. 3;

FIG. 4 b is a rear elevational view of the retainer of FIG. 3;

FIG. 5 is a side elevational view of the retainer of FIG. 3;

FIG. 6 is a top plan view of a catheter anchoring system in accordancewith another preferred embodiment of the present invention;

FIG. 7 a is a front elevational view of a retainer and rail assembly ofthe catheter anchoring system of FIG. 6;

FIG. 7 b is a side elevational view of the retainer and rail assembly ofFIG. 6;

FIG. 8 is a cross-sectional view of the retainer and rail assembly takenalong line 8-8 of FIG. 7 a;

FIG. 9 is a top plan view of a catheter anchoring system in accordancewith an additional preferred embodiment of the present invention;

FIG. 10 is a side elevational view of an S-clip of the catheteranchoring system of FIG. 9 taken along line 10-10;

FIG. 11 is a top perspective view of a catheter anchoring system inaccordance with an additional preferred embodiment of the presentinvention;

FIG. 12 is a top plan view of the catheter anchoring system of FIG. 11illustrating an adaptor held by a retainer;

FIG. 13 a is a side elevational view of the retainer of FIG. 12;

FIG. 13 b is a top plan view of the retainer of FIG. 12;

FIG. 14 is a partially sectioned perspective view of an alternativeembodiment of a catheter adaptor which may be used with the anchoringsystem of FIG. 11;

FIG. 15 a is side elevational view of a catheterization system inaccordance with another preferred embodiment of the present inventionwith a retainer of the catheterization system shown in cross-section;

FIG. 15 b is a top plan view of the retainer of FIG. 15 a as viewed inthe direction of arrows 15 b-15 b;

FIG. 15 c is a front end elevational view of the retainer of FIG. 15 aas viewed in the direction of arrows 15 c-15 c; and

FIG. 16 is a perspective view of a catheterization system configured inaccordance with another embodiment of the present invention, andillustrates a catheter in a position separate from a retainer of thecatheterization system;

FIG. 17 is a perspective view of a catheterization system configured inaccordance with another embodiment of the present invention, andillustrates the a catheter adaptor having a plurality of radial recessesand a retainer having a plurality of projections that cooperate with therecesses when the retainer receives the catheter adaptor; and

FIG. 18 is a perspective view of the catheterization system configuredin accordance with an additional embodiment of the present invention,and illustrates the catheter adaptor having a plurality of radialrecesses and a retainer having a plurality of projections that extendinto a channel having a tapered diameter.

DETAIL DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 illustrates in perspective view a catheter anchoring system 10 inaccordance with the present invention. The anchoring system 10 securelyconnects a tube 12 (e.g., a fluid supply tube) to an indwelling catheter14 and maintains the catheter 14 in the desired indwelling position. Theanchoring system 10 is designed for rapid attachment to the catheter 14and to the patient, without requiring precise alignment or positioningof the components of the anchoring system 10.

Moreover, sturdy anchoring of the catheterization system is achievedwithout the use of surgical tape. For most catheterization, theanchoring system is attached to the patient only once. Although thefluid supply tubing 12 may be replaced every 24 to 48 hours forintravenous catheterization, the components of the anchoring system 10attached to the patient remains in place. Thus, surgical tape need notbe applied and removed from the patient's skin on multiple occasions.

The catheter anchoring system 10 principally comprises a flexible pad 16having an adhesive bottom side 18 which attaches to the skin of apatient when used. The pad 16 supports a retainer 20. The retainer 20 isconfigured to receive and secure in place a catheter adaptor 22 whichinterconnects the hub 30 of an indwelling catheter 14 and the fluidsupply tube 12 connected to a fluid supply container (not shown). Thecontainer maintains the fluid to be dispensed to the patient which isfed either by gravity or by pressure. A clamp (not shown) may be used toregulate the fluid flow through the tubing 12. The pad 16 may alsosupport a tubing clip 24 which is used to retain a portion of tubing 12.

Although FIG. 1 illustrates the catheter anchoring system located on theback of a patient's hand (illustrated in phantom lines), it iscontemplated that the present invention may be used for catheterizationin other locations on the patient's body. For instance, the anchoringsystem may be used on the medial side of the wrist in connection with aradial artery. The anchoring system 10 may also be used for epiduralcatheterization, as discussed in detail below, and thus located on theanterior or posterior of the patient's torso.

FIG. 1 illustrates a longitudinal axis, a transverse axis and a lateralaxis in relation to the catheter anchoring system 10 to facilitate thefollowing description. Additionally, as used herein, “the longitudinaldirection” refers to a direction substantially parallel to thelongitudinal axis. “The lateral direction” and “the transversedirection” are in reference to the lateral axis and transverse axis,respectively. Also, “proximal” and “distal” are in reference to theproximity of the fluid supply container attached to the tube 12 (seeFIG. 1). The individual components of the catheter anchoring system 10will now be described in detail.

Catheter Adaptor

FIG. 1 illustrates the catheter adaptor 22 interconnected with acatheter 14. FIG. 2 illustrates the catheter adaptor 22 disconnectedfrom catheter 14. Although these figures illustrate the adaptor 22 asthe type disclosed in U.S. Pat. No. 5,193,273, it is contemplated thatother types of adaptors can be used as well with the present catheteranchoring system 10. For instance, the catheter adaptor 22 could be alure-type adaptor, such as the type illustrated by FIG. 11 and describedbelow, or a lure-lock type catheter adaptor 22, such as the typeillustrated by FIG. 14 and described below. It is contemplated thatthose skilled in the art could readily select the type of catheteradaptor 22 to be used with the present catheter anchoring system 10depending on the particular application (e.g., venous, arterial,epidural, peripheral, etc.) of the anchoring system 10.

As best seen in FIG. 2, the adaptor 22 comprises a tubular body 25defined between a distal end 26 and a proximal end 28. The proximal end28 is adapted to receive a distal end of the tube 12. In an exemplaryembodiment, at least a portion the fluid supply tube is permanentlyattached to the body proximal end 28. As shown in FIG. 2, the proximalend of the tubing may then include a standard lure-type connector 29 toconnect into a fluid supply line 12.

The distal end 26 is configured to engage the proximal hub 30 of thecatheter 14 (see FIG. 1) or any lure-type connector. Although FIG. 2illustrates the distal end of the adaptor 22 as having a frusto-conicalshape configured to engage a standard lure-type catheter hub 30, it iscontemplated that the distal end 26 could be configured as well toengage other types of catheter connectors, such as, for example, aToughy-Bourst adaptor.

A support arm 32 extends outwardly from the tubular body 25 incantilever fashion. The support arm 32 supports, on a radially outer endof the arm 32, a clip support element (not shown) that extends generallyparallel to and is spaced from a longitudinal axis of the tubular body25.

FIG. 2 further illustrates a clip 34 of the catheter adaptor. The clip34 attaches to and slides over the clip support element in thelongitudinal direction. The clip 34 includes a distal latch 36 which hasa generally forked shape to engage a outer surface of the catheter hub30 distal of a hub collar 38 (see FIG. 1) to securely attach the adaptor22 to the catheter hub 30.

Interengaging structure (not shown) between the clip support element andthe clip 34 permits the clip 34 to slide in the proximal direction, butprevents the clip 34 from sliding in the distal direction. Theinterengaging element desirably comprises a series of ratchet teeth (notshown) disposed up on upper surface of the clip support element and apawl (not shown) connected to the clip 34. The pawl extends from theclip 34 in a cantilever fashion and engages the ratchet teeth to preventdistal movement of the clip, as discussed in detail in U.S. Pat. No.5,193,273, which has been incorporated by reference.

The tubular body 25, the support arm 32 and the clip support element arepreferably integrally formed of molded plastic, such as, for example, aclear polycarbonate, so as to be generally stiff, but somewhat flexible.The support arm 32 desirably has enough elasticity to bend. Depressingthe proximal end of the clip 34 towards the tubular body 25 moves thelatch 36 of the clip 34 away from the tubular body 25. In this manner,the clip 34 pivots about the tubular body 25.

With reference again to FIG. 2, the clip support element desirablycomprises a protuberance 40 positioned on an inner surface 42 of theclip support element, proximate to the proximal end of the clip 34. Theprotuberance is spaced from the support arm by a distance L. Theprotuberance 40 prevents the clip 34 from pivoting when secured by theretainer 20, as discussed below in detail. The protuberance 40 alsolimits the degree of deflection of the support arm 32 to reduce fatigue,as fully explained in U.S. Pat. No. 5,193,273, which has beenincorporated by reference.

Retainer for Catheter Adaptor

FIGS. 3 through 5 illustrate the retainer 20. The retainer 20 has agenerally parallelepiped shape defining a central channel 44 interposedbetween a pair of opposing longitudinal walls 46. The central channel 44extends through the retainer 20 along an axis which is generallyparallel to the longitudinal axis of the retainer.

As best seen in FIG. 4, the central channel 44 has a generally circularcross-sectional shape which is truncated at a upper end to form agenerally U-shaped channel having an upper opening 47. The centralchannel 44 has a diameter sized to receive the tubular body 25 of thecatheter adaptor 22. In a preferred embodiment, the diameter of thecentral channel 44 generally matches that of the tubular body 25 or isslightly larger.

In cross-section, the central channel 44 extends through an arc greaterthan 180N about the channel axis such that the transverse length of theopening 47 is less than the diameter of the central channel 44. In anexemplary embodiment, the central channel 44 extends through an arc ofabout 200N about the channel axis.

FIG. 5 illustrates the channel axis which is desirably skewed relativeto a base surface 48 of the retainer 20. An incident angle θ formedbetween the base surface 48 and the channel axis is less than 45N. Theincident angle θ desirably ranges between 0N and 30N. In an exemplaryembodiment for intravenous use, the angle θ preferably equalsapproximately 7N. In another exemplary embodiment for arterial use, theincident angle θ preferably equals about 22N. In a further exemplaryembodiment, for peripherally inserted central catheters (PICC), theincident angle θ preferably equals 0N.

The longitudinal walls 46 are substantially identical. Each wall 46 hasa thickness measured in the lateral direction less than the length ofthe support arm 32. The wall 46 is thus interposed between the tubularbody 25 and the clip 34 when the tubular body 25 is inserted into thecentral channel 44. The length of each wall 46, measured in thelongitudinal direction, is preferably coextensive with the length of theretainer 20.

Each wall 46 comprises a uniform series of slots 50. The seriescomprises at least two (2) slots 50, and not more than twenty (20) slots50. More preferably, the series comprises less than seven (7) slots 50.In an exemplary embodiment, as illustrated in the figures of theapplication, the series comprises four (4) slots 50.

Each slot 50 is sized to receive the support arm 32 of the catheteradaptor 22 to prevent longitudinal displacement of the adaptor 22, asdiscussed in detail below. Each slot 50 desirably has a rectangularshape. As seen in FIG. 3, the slots 50 extend from an exterior surface52 through the wall 44, and open into the central channel 44. The widthof each slot 50 (measured longitudinally) is desirably slightly greaterthan the width of the support arm 32, measured in the longitudinaldirection to receive the support arm 32, as discussed below.

As illustrated by FIG. 5, each slot 50 has a height as measured in thetransverse direction between an upper edge 54 of the longitudinal wall46 and the bottom 56 of the central channel 44. The height of the slot50 desirably equals approximately the width of the support arm 32 suchthat the support arm 32 does not protrude from the retainer 20 in thetransverse direction.

The spacing S between the slots 50, on center, desirably equals abouthalf the distance L (see FIG. 2) between the support arm 32 and theprotuberance 40 of the catheter adaptor 22.

As FIG. 3 illustrates, a distance X between the most distal slot 50 andthe distal end of the retainer 20 is less than the longitudinal distanceY (see FIG. 2) between the support arm 32 and the latch 36 positioned inits most proximal position. This spacing enables the support arm 32 torest in the most distal slot 50 with the latch 36 retaining a catheterhub 30 distal of the retainer distal end.

FIG. 5 illustrates the upper edge 50 of the longitudinal wall 46 whichcomprises a series of chamfers 58, each of which slopes into a slot 50.That is, the portion of upper edge 50 of the longitudinal wall 46 whichsurrounds a slot 50 includes a pair of chamfers 58, with one chamfer 58located on either side of the slot 50. The chamfers 58 slope downwardtoward the slot 50 to facilitate the insertion of the support arm 32 ofthe catheter adaptor 22 into the slot 50, as discussed below.

As shown by FIGS. 3 and 5, each longitudinal wall 46 further comprises arelief 60 disposed on the proximal end of the retainer 20. The relief 60is sized to receive the protuberance 40 of the adaptor 22. The depth ofthe relief 60 measured in the lateral direction desirably is slightlygreater than the height of the protuberance 40 (i.e., the distance bywhich the protuberance protrudes from the inner surface 42).

The relief 60 is spaced in the longitudinal direction from the mostproximal slot 50 by a distance approximately equal to the spacing Sbetween the slots 50. Thus, the protuberance 40 rests in the relief 60with the support arm 32 positioned in either of the two most proximalslots 50, as discussed in detail below.

FIGS. 3 and 4 illustrate a key-way groove 62 of the retainer 20. Thekey-way groove 62 facilitates the removal of the catheter adaptor 22from the retainer 20, as discussed below in detail. The key-way groove62 lies at the proximal end of the retainer 20. The key-way groove 62extends into the retainer 20, and toward the retainer base surface 48from the bottom surface 56 of the central channel 44. The key-way groove62 has a transverse width less than the diameter of the central channel44, and more preferably has a width approximately equal to two-thirdsthe diameter of the central channel 44. The longitudinal length of thekey-way groove 62 desirably equals approximately the longitudinal lengthof the recesses 60 in the longitudinal walls 46.

The retainer 20 is made of relatively stiff plastic material (e.g.,polycarbonate), but is somewhat flexible such that the adaptor 22 forcesthe upper edges 54 of the longitudinal walls 46 outwardly when a nursepresses the adaptor 24 into the central channel 44 of the retainer 20.When the adaptor 22 sits in the central channel 44, the upper edges 54of the walls 46 snap inwardly to their original position to securelyhold the adaptor 22 within the retainer 20.

An adhesive attaches the retainer 20 to base pad 16. Alternatively, theretainer 20 may be attached to the base pad 16 by like means (e.g.,embedding or otherwise weaving the retainer 20 into the base pad 16) aswell.

Base Pad

As illustrated by FIG. 1, the flexible base pad 16 comprises a laminatestructure comprising an upper paper or other woven or non-woven clothlayer 64, an inner cellulose foam layer 66, and the bottom adhesivelayer 18. Alternative, the flexible base pad 16 may comprise an adhesivebottom layer and an upper cellulose foam layer. An upper surface of thefoam layer is roughened by corona treating the foam with a low electriccharge, as known in the art. The roughened or porous upper surface ofthe base pad 16 improves cyano-acrylate (or other types of adhesive)adhesion when attaching the retainer 20 to the pad 16.

A removable paper or plastic backing (not shown) desirably covers thebottom adhesive layer 18 before use. The backing preferably resiststearing and is divided into a plurality of pieces to ease attachment ofthe pad 16 to the patient's skin, as explained below. Desirably, thebacking is split along the center line of the flexible base pad 16 inorder to expose only half of the adhesive bottom surface 18 at one time.The backing also advantageously extends beyond at least one edge of thebase pad 16 to ease removal of the backing from the adhesive layer 18.

As seen in FIG. 2, one or more tabs 67 may be attached to a portion ofthe backing which extends beyond the flexible base pad 16. In anexemplary embodiment, the tabs 67 have the same laminate structure asthe flexible base pad 16. The tabs 67 also can be formed by the paperbacking extending beyond the edge of the base pad 16. The tab 67 mayalso include indicia 69 in the form of dots, words, figures or the liketo indicate the placement of fingers when removing the backing from thebase pad 16.

A nurse grips the tab 67, preferably at the location of the indicia 69,and peels the backing off one half of the bottom adhesive layer 18. Thenurse then places the bottom layer 18 against the patient's skin toadhere the base pad 16 to the patient. Light pressure over the upperlayer 64 assures good adhesion between the base pad 16 and the patient'sskin. The base pad 16, due to its flexibility, conforms to the contoursof the topical surface to which the base pad 16 adheres. The nurse thenrepeats this procedure for the other half of the pad 16. Alternatively,the nurse may completely remove the backing from the pad 16 beforeattaching the pad 16 to the patient's skin.

The base pad 16 desirably comprises a notch 68 positioned distal of thelocation of the retainer 20 on the pad 16 and adjacent to the point ofinsertion of the catheter cannula. The notch 68 is sized to permitvisual inspection of the catheterized site.

As seen in FIG. 2, the base pad 16 desirably may comprise indicia 70 inthe form of an arrow which indicates the proper orientation of the basepad 16 in reference to catheterized site. Although the figuresillustrate the indicia in the form of an arrow, it is contemplated thatother forms of indicia, such as, for example, words or other graphics,could be used as well. In proper use, as illustrated in FIG. 1, theindicia 70 should point in the proximal direction, towards theindwelling catheter 14, or otherwise indicate the proper locate of thepad 16 in reference to the indwelling catheter 14.

In an exemplary embodiment, the laminate structure of the base pad ispreferably formed by rolling a paper tape, such as a micro-porous rayontape, available commercially as MICRO-PORE tape from 3M (Item No. 1530),over a medical grade polyvinyl chloride foam tape, such as thatavailable commercially from 3M (Item No. 9777L). The foam tapepreferably includes the bottom liner or backing. The base pad 16 and thetabs 67 are then stamped out of the laminated sheet of foam and paper.The backing between the tabs and the base pad, however, is desirably notsevered such that the tabs 67 remain attached to the backing coveringthe adhesive section 18 of the base pad 16. The backing is then cut intotwo pieces along the center line of the pad 16 and between the tabs 67.

Tube Clip

FIGS. 1 and 2 illustrate the tube clip 24. The clip 24 secures the fluidsupply tube 12 to form a safety loop, as known in the art.

The tube clip has a plate-like base 72 adhered to or embedded in thebase pad 16. The tube clip 24 may be located on the base pad 16 oneither side of the retainer 20 to accommodate left hand or right handmounting. As illustrated in FIG. 6, the anchoring system 10 may furtherinclude a second tube clip 24 located on the other side of the retainer20 from the first tube clip 24.

The clip 24 defines a channel 74 having a generally circularcross-sectional configuration truncated to form an upper orifice 76. Thediameter of the channel 74 is desirably slightly less than that of thefluid supply tube 12 so as to ensure a secure interconnection. Thechannel 74 receives a portion of the fluid supply tube 12 through theorifice 76 upon application of gentle pressure or by pulling the tubing12 across and through the orifice 76 of the tube clip 24, as explainedbelow. The clip 24 surrounds a substantial portion of the tubing 12 withthe tubing 12 positioned within the channel 74.

As seen in FIG. 2, the upper edge of the channel includes tapered ends77 at the proximal and distal ends of the clip 24. Each tapered end 77forms a smooth transition between the side edge of the channel 74 andthe upper edge, and tapers in lateral width from the side edge towardthe center of the tube clip 24. The tapered ends 77 help guide the fluidsupply tube 12 into the channel 74 when a nurse pulls the tube acrossthe clip 24. Thus, the nurse does not have to pinch the tube 12 toinsert it into the clip 24. Also, the nurse's gloves do not get stuck inthe clip 24 when inserting the tube 12, as is typically the case wherethe nurse is required to pinch the tube 12 to insert it into the clip24.

Slide Clamp

As illustrated in FIGS. 1 and 2, the catheter anchoring system 10desirably additionally includes a slide clamp 78 to regulating fluidflow through the tubing, as known in the art. The clamp 78, at one end,includes an aperture 80 which receives the fluid supply tube 12, and, atthe opposite end, includes a tab 82. The clamp 78 has a generally forkedshape formed by a pair of prongs 84 which defines the aperture 80. Thetube 12 snaps between the prongs 84 and into the aperture 80, which hasa diameter slightly larger that the fluid supply tube 12.

The prongs 84 converge together in the direction towards the tab 82 toform a tapering slot 86 which opens into the aperture 80. The prongs 84pinch the tube 12 closed with the tube 12 positioned in the slot 86 soas to block fluid flow therethrough. The clamp 78, however, slides overthe tube 12 with the tube 12 positioned through the aperture 80.

The tab 82 desirably has a rectangular shape which generally correspondsthe to shape of the key-way groove 62 of the retainer 20. The tab 82preferably has a thickness greater than that of the distal end ofkey-way groove 62, measured in the transverse direction, so as to prythe adaptor 22 from the retainer 20. As explained in detail below, thetab 82 may be used to remove the catheter adaptor 22 from the retainer20.

Retainer Location Adjustment Mechanism

FIG. 6 through 8 illustrate a catheter anchoring system 10 a inaccordance with another preferred embodiment of the present invention.Where appropriate, like numbers with an “a” suffix have been used toindicate like parts of the two embodiments for ease of understanding.

The catheter anchoring system 10 a is substantially identical to theabove-described anchoring system 10, with the addition of a retainerlocation adjustment mechanism 90.

As best seen in FIG. 8, the location adjustment mechanism 90 comprises abase 92 and interlocking mechanism 94 which interconnects the base 92and the retainer 20 a. The retainer 20 a slides over the base 92 and theinterlocking mechanism 94 secures the retainer 20 a to the base 92 atvarious longitudinal positions. The adjustment mechanism thus allows forprecise positioning of the retainer 20 relative to the catheter 14 afterthe pad 16 is attached to the patient's skin.

The base 92 has a generally parallelepiped shape and comprises a rail96. FIG. 7 a best illustrates that the rail 96 desirably has a“dove-tail” configuration in cross section. That is, the rail 96 has across-sectional shape with a flat upper edge 98 and a pair of opposingside edges 100, each edge 100 being angled inward from the upper edge 98toward the middle of the rail 96. The rail 96 extends along thelongitudinal length of the base 92 from the distal end 102 of the base92 to a point just short of the base proximal end 104. The base 92includes a pair of stops 106 at the proximal end 104 which close off theproximal end of the rail 96.

An adhesive attaches the base 92 to base pad 16 a. Alternatively, thebase 92 may be attached to the base pad 16 a by like means (e.g.,embedding or otherwise weaving the base 92 into the base pad 16 a) aswell.

The retainer 20 a, configured in accordance with the above-description,additionally comprises a groove 108 having a cross-sectional shapecorresponding to that of the rail 96. The retainer groove 108 receivesthe base rail 96 in a manner permitting the retainer 20 a to slide overthe base 92, but preventing the retainer 20 a from moving in thetransverse direction away from the base 92. The base stops 106 alsolimit the retainer's longitudinal travel in a proximal direction.

The interlocking mechanism 94 comprises a plurality of teeth 110disposed on an upper surface 112 of the base 92, and a pawl 114connected to the retainer 20 a. The teeth 110 desirably have generallyrectangular cross-sectional shapes, and lie in seriatim along thelongitudinal axis of the base 92. The upper edge of each tooth 110includes a chamfer 112 to facilitate the engagement of the pawl 114 witha hollow 116 formed between adjacent teeth 110, as discussed below. Thelongitudinal length of each tooth 110 desirably extends generally normalto the longitudinal axis of the base 92.

The pawl 114 has a shape configured to insert into and engage with thehollow 116 defined between the teeth 110. The pawl 114 preferably has awidth, measured in the longitudinal direction, slightly less than thatof the hollow 116.

The retainer 20 a comprises an aperture 118 extending between theretainer base surface 48 a and the channel bottom surface 56 a. Aflexible finger 120 extends from the retainer 20 a in a cantileverfashion and into the retainer aperture 118. The flexible finger 120supports the pawl 114 at its distal end. Although FIG. 8 illustrates thefinger 120 as extending in the distal direction, it is contemplated thatthe finger 120 can alternatively extend in the proximal direction aswell.

The flexible finger 120 preferably comprises a protuberance 122 whichextends upwardly beyond the channel bottom surface 56 a and into thecentral channel 44 a with the finger 120 in an undeflected state. Thecantilever nature of the finger 120 enables the finger 120 to deflectdownward so that the protuberance 122 lies below the retainer bottomsurface 56 a. With the finger 120 so deflected, the pawl 114 engages theseries of teeth 110. That is, the pawl 114 inserts into a hollow 116defined between the teeth 110. The interengagement between pawl 114 andthe teeth 110 prevents the retainer 20 a from sliding over the base 92.

S-Clip

FIGS. 9 and 10 illustrate a catheter anchoring system 10 b in accordancewith a further embodiment of the present invention. Where appropriate,like numbers with an “b” suffix have been used to indicate like parts ofthe embodiments for ease of understanding.

The catheter anchoring system 10 b is substantially identical to theanchoring system 10 first described above, with the addition of anS-clip 124 to retain a microbore or small bore tubing 126. The microboretubing is commonly used, for example, with epidural catheterizationprocedures, as discussed in detail below.

The S-clip 124 comprises a generally U-shaped channel 128 defined by apair of arcuate, upstanding walls 130 extending from a base plate 132.As best seen in FIG. 10, the S-clip 124 further comprises a plurality ofretainers 134, each retainer 134 having a spherical head 136 support bya cylindrical stem 138. The stems 138 extend from the base plate 132.The retainer stems 138 are positioned from one another and from theupstanding walls 130 by a distance slightly greater than the diameter ofthe microbore tubing 126. The retainers 134 are also positioned suchthat the spherical heads 136 of the retainers 134 are positioned fromone another and from the upstanding walls 130 by a distance slightlyless than the microbore tubing 126. As best seen in FIG. 10, theretainer heads 136 prevent the microbore tubing 126 from disengagingfrom the S-clip 124 in the transverse direction once the microboretubing 126 is snaked between the retainers 134 and the upstanding walls130.

An adhesive attaches the base plate 132 of the S-clip 124 to base pad 16b. Alternatively, the base plate 132 may be attached to the base pad 16b by like means (e.g., embedding or otherwise weaving the base plate 132into the base pad 16 b) as well.

The components of the anchoring system 10, save the base pad 16 (i.e.,the retainer 20, tube clip 24, adaptor 22, slide clamp 78, base 92 andS-clip 124), may be constructed in any of a variety of ways which willbe well known to one of skill in the art. For instance, each individualcomponent may be integrally molded such as by injection molding or bythermoplasty. The components preferably comprise a durably, flexiblematerial, and more preferably comprise a generally inert, non-toxicmaterial. In a preferred embodiment, the components are molded ofplastic, such as, for example, polycarbonate, polyvinylchloride,polypropylene, polyurethane, tetrafluoroethylene (e.g., TEFLON7),polytetrafluoroethylene (a.k.a., PTEF), acetal resin (e.g., DELRIN7),chlorotrifluoroethylene (e.g., KEL-F7), nylon or like polymers.

Method of Use

The following discussion of the method of use will be with reference toFIGS. 1 and 2, and initially will be in the context of intravenouscatheterization. As the following discussion will illustrate, however,it is understood that the anchoring system 10 can be used in othercatheterization procedures as well. The discussion of the method of useis intended to augment the above description of the invention, and,thus, should be read together.

A nurse typically begins the catheterization process by positioning thecatheter 14 at a desired location above a vein. The nurse introduces aneedle or other stylus through a cannula portion of the catheter 14 andinto the skin of the patient at a desired angle of incident. Forintravenous use, the catheter 14 commonly has an incident angle ofapproximately 7N. The nurse then inserts the cannula of the catheter 14into the patient and withdraws the needle or stylus. The catheter hub 30remains exposed above the skin.

The nurse inserts the distal end of the adaptor 26 into the catheter hub30. The clip 34 has been slidably mounted in a most distal position sothat it does not interfere with the insertion of the adaptor distal end26 into the catheter hub 30.

The nurse then slides the clip 34 in a proximal direction to engage thecatheter hub 30. In this manually selected position, the clip 34securely attaches the adaptor 22 to the catheter 14. The ratchet teethof the adaptor 22 cooperate with the pawl to resist distal movement ofthe clip 34 and to hold the clip 34 in the manually selected position.

The nurse removes the paper backing which initially covers the adhesivebottom surface 18 of the base pad 16, and attaches the pad 16 to thepatient's skin proximate to the indwelling catheter 14. Specifically,the nurse grips the backing tab 67 proximate to the retainer 20. Theindicia 69 on the tab 67 indicates the locate at which the nurse shouldgrip the tab 67. The nurse then pulls on the tab 67 and peels thebacking off one half of the bottom adhesive layer 18. The nursepositions the slot 68 of the pad 16 around the catheter cannula 14 withthe instructing indicia 70 (e.g., indicating arrow) pointing in thedirection of the catheter 14. The nurse then places the bottom layer 18against the patient's skin to adhere the base pad 16 to the patient.Light pressure over the upper layer 64 assures good adhesion between thebase pad 16 and the patient's skin. The base pad 16, due to itsflexibility, conforms to the contours of the topical surface to whichthe base pad 16 adheres.

The nurse then repeats this procedure for the other half of the pad 16.Alternatively, the nurse may completely remove the backing from the pad16 before attaching the pad 16 to the patient's skin.

The nurse orients the adaptor 22 with the clip 34 positioned to the sideof the tubular body 25 (i.e., with the support arm 32 extending in thelateral direction) and locates the adaptor support arm 32 above theseries of retainer slots 50 with the latch 36 positioned distal of theretainer distal end.

The nurse then snaps the adaptor 22 into the retainer 20 locatedproximal of the pad notch 68. In doing so, the adaptor 22 is pressedbetween the longitudinal walls 46 of the retainer 20 with the supportarm 32 extending in a lateral direction. As the nurse presses theadaptor 22 into the retainer 20, the chamfered edges 58 around the slots50 of the longitudinal wall 46 guide the support arm 32 into one of theslots 50.

As mentioned above, the opening 47 of the channel 46 has a smaller widthmeasured in the lateral direction than the diameter of the tubular body25. The lateral walls 46 thus deflect outwardly in a lateral direction.Once the tubular body 25 of the adaptor 22 rests within the centralchannel 44 of the retainer 20, the lateral walls 46 spring back to snapthe adaptor 22 in place. The walls 46 of the retainer 20 thus preventunintentional transverse and lateral movement of the adaptor 22.

In this position, the protuberance 40 of the adaptor 22 either restseither in a slot 50 or in the relief 60, proximal of the slot 50 throughwhich the support arm 32 passes. The protuberance 40 engages a portionof the longitudinal wall 46, which forms either the relief 60 or theslot 50, to prevent the clip 34 from pivoting relative to the tubularbody 25. The protuberance 40 thus ensures that the latch 36 maintainsengagement with the catheter hub 30.

The slot 50 through which the support arm 32 passes prevents the adaptor22 from sliding in the longitudinal direction. That is, the slot 50prevents longitudinal displacement of the adaptor 22 when secured withinthe central channel 44.

The ergonomic design of the retainer 20 provides for a variety ofpositions of the adaptor 22 in the retainer 20 so that the retainer 22is not technique or position sensitive. That is, a nurse can simplypress the adaptor 22 into the retainer 20, irrespective of the side onwhich the support arm 32 is located, and irrespective of the position ofthe support arm 32 relative to a particular slot 50. So long as thesupport arm 32 is positioned above the series of slots 50, the chamferededges 58 of the wall 46 will guide the support arm 32 into a slot 50.The protuberance 40 of the adaptor 22 also fits within an adjacent slot50 or the relief 60.

With the support arm 32 extending through a slot 50 of the retainer 20,the adaptor 22 lies in a “low profile” position. That is, the supportarm 32 of the adaptor 22 extends in the lateral direction to reduce theoverall height of the anchoring system 10, as measured in the transversedirection. This position of the adaptor 22 reduces the risk of thesystem 10 interfering with surrounding action. The retainer 20, however,allows the adaptor 22 to rotate either to a position in which thesupport arm 32 extends in the transverse direction, or to a position180N for the original position to locate the adaptor clip 34 on theopposite side of the retainer 20.

Once in the low profile position, the adaptor 22 will normally remain inthis position until the adaptor 22 and its associated tubing 12 areremoved and replaced by another.

As FIG. 1 illustrates, the nurse may also form a safety loop in thefluid supply tubing 12, as known in the art, and secure the safety loopto the patient by inserting a portion of the tubing 12 into the tubeclip 24. The safety loop absorbs any tension applied to the fluid supplytube to prevent the adaptor 22 and/or catheter 14 from being pulled.

A nurse may use the slide clamp 78 to remove the adaptor body 25 fromthe retainer 20. The nurse inserts the tab 82 of the slide clamp 78 intothe key-way groove 62 on the proximal end of the retainer 20. Becausethe tab 82 has a larger width than the depth of the key-way groove 62,measured in the transverse direction, the tab 62 pries the tubular body25 from the central channel 44 as the nurse inserts the tab 82 into thekey-way groove 62 in the distal direction. The nurse may further use theslide clamp 78 to leverage the proximal end of the tubular body 25 outthe upper opening 47 of the retainer 20. Having displaced the proximalend of the adaptor 22 from the retainer 20, the nurse may easily removethe adaptor distal end from of the retainer 20. Alternatively, the nursemay also remove the tubular body 25 by lifting up on the tubing 12 whileholding down the pad 16 or the retainer 20 with the other hand.

FIGS. 6 through 8 illustrate the catheter anchoring system 10 aparticularly suited for arterial catheterization. Because of thecriticality of the incident angle (i.e., the angle at which the catheter14 a projects into the patient) at which the catheter 14 a must bemaintained, it is advantageous to precisely position the retainer 20 aso that the retainer 20 a holds the catheter 14 a at the desiredincident angle. The desired range of incident angle commonly is about5N-30N for arterial catheterization. The incident angle preferablyranges between about 15N and about 25N, and more preferably equals about22N.

A nurse inserts the catheter cannula 14 a into an artery in a similarmanner to that described above in connection with intravenouscatheterization. The nurse subsequently connects the adaptor 22 a to theindwelling catheter 14 a as previously described. The nurse alsoattaches the flexible pad 16 a to the patient in a like manner to thatdescribed above. If desired, the nurse can remove one of the wings 140of the pad 16 a before attaching the pad 16 a to the patient, by tearingthe pad 16 a along the perforation line 142.

The nurse orients the adaptor 22 a with the clip 34 a positioned to theside of the tubular body 25 a (i.e., with the support arm 32 a extendingin the lateral direction) and locates the adaptor support arm 32 a abovethe series of retainer slots 50 a with the latch 36 a positioned distalof the retainer distal end. If the nurse positions pad 16 a too close toor too far from the indwelling catheter 14 a, the nurse can slide theretainer 20 a in the desired direction to locate the retainer slots 50 abeneath the adaptor support arm 32 a.

The nurse then snaps the adaptor 22 a into the retainer 20 a locatedproximal of the pad notch 68 a. In doing so, the chamfered edges 58 aaround the slots 50 a of the longitudinal wall 46 a guide the supportarm 32 a into one of the slots 50 a. The retainer 20 a automaticallyslides longitudinally to precisely position a corresponding slot 50 abeneath the support arm 32 a. The adaptor 22 a thus snaps into theretainer 20 a without causing the catheter 14 a to move substantially.

The tubular body 25 a contacts the protuberance 122 of the finger 120and causes the finger 120 to deflect downward as the adaptor tubularbody 25 a snaps into the central channel 44 a. In turn, the pawl 114engages the series of teeth 110 which prevents longitudinal movement ofthe retainer 20 a while holding the adaptor 20 a. If the nurse removesthe adaptor 22 a—preferably by using the slide clamp tab 82 a—the finger120 springs back to its undeflected state and the retainer 20 a freelyslides over the rail 96. The pawl 114 normally does not engage theseries of teeth 110.

The ability to precisely position the retainer 20 a beneath the catheteradaptor 22 a connected to the catheter 14 a, enables the nurse to holdthe catheter 14 a in a stable position and ensures that the retainer 20a will hold the adaptor 22 a, and thus the catheter 14 a, at the preciseincident angle. Without the ability to adjust the longitudinal positionof the retainer 20 a, the nurse may perform a series of positioniterations before properly locating base pad 16 a, and thus the retainer20 a, relative to the indwelling catheter 14 a.

For epidural catheterization, an anesthesiologist, for example, insertsthe distal end of microbore tubing 126 into the epidural space. Theproximal end of the microbore tubing 126 conventionally includes aToughy-Bourst adaptor 144 or other adaptor device to couple with thefluid supply tube 12 b transporting the anesthesia. It is imperativethat the connection between the microbore tubing 126 and the fluidsupply tubing 144 remain intact, and that the distal end of themicrobore tubing 126 remains in place. For if the epidural space isexposed to air-borne microbes, meningitis may develop. Thus, a secureinterconnection between the microbore tubing 126 and the fluid supply 12b should exist and the microbore tubing 126 should be isolated from anytension placed on either the fluid supply tube 12 b, as well as theadaptor 22 b.

FIGS. 9 and 10 illustrate the catheter anchoring system 10 bparticularly suited for epidural catheterization. A doctor uses thepresent anchoring system 10 b in a manner similar to that describedabove in connection with intravenous catheterization, with theexceptions that doctor connects the adaptor 22 b to microbore tubing 126and adheres the base pad 16 b to the patient's torso.

The doctor subsequently snakes the microbore tubing 126 through theS-clip 124 by first pressing the tubing 126 between a retainer 134 andthe wall 130, and then wrapping the tubing 126 between the first andsecond retainers 134. Light pressure forces the tube 126 between theretainers 134. The doctor then wraps the tube 126 back between thesecond retainer 134 and the second wall 130, and presses the tube 126therebetween. The S-clip 124 secures the microbore tube 126 in place andisolates the microbore tube 126 from tension placed on the adaptor 22 band/or the fluid supply tube 12 b with the microbore tube 126 insertedaccordingly.

Additional Embodiments

As mentioned above, it is contemplated that other types of adaptors inaddition to the one disclosed above can be used as well with the presentcatheter anchoring system. FIGS. 11 and 12 illustrate a catheteranchoring system 10 c in accordance with a further embodiment of thepresent invention which includes a different catheter adaptor style.Where appropriate, like numbers with a “c” suffix have been used toindicate like parts of the embodiments for ease of understanding.

Like the catheter anchoring systems described above, the presentcatheter anchoring system 10 c principally comprises a flexible anchorpad 16 c having an adhesive bottom side 18 c, which attaches to the skinof the patient. The pad 16 c supports a retainer 20 c. The retainer 20 cis configured to receive and secure in place a catheter adaptor 22 cwhich connects to an indwelling catheter 14 c. The pad 16 a may alsosupport a tube clip 24 c which is used to retain a portion of the tubing12 c.

FIG. 11 illustrates the adaptor 22 c as comprising a generally tubularbody 25 c defined between a distal end 26 c and a proximal end 28 c. Theproximal end 28 c is adapted to receive a distal end of the tube 12 c.In an exemplary embodiment, at least a portion of the fluid supply tube12 c is permanently attached to the body proximal end 28 c.

The distal end 26 c is configured to engage a proximal end of theindwelling catheter 14 c (not shown). Although FIGS. 11 and 12illustrate the distal end 26 c of the adaptor 22 c as having afrusto-conical shape configured to engage a standard lure-type catheterhub 30 c (not shown), it is contemplated that the distal end 26 c couldbe configured as well to engage other types of connectors.

FIG. 14 illustrates an alternative configuration of the distal end 26 dof the catheter adaptor 22 d. Again, for consistency, like numbers witha “d” suffix have been used to indicate like parts of the catheteradaptor of FIG. 11 and the catheter adaptor of FIG. 14.

The catheter adaptor 22 d includes a standard lure-lock type fitting 220attached to the body 25 d of the catheter adaptor 22 d so as tocircumscribe the distal end 26 d of the catheter adaptor 22 d. Thelure-lock fitting 220 preferably is attached in a manner which permitsthe fitting 220 to be rotated about the catheter adaptor body 25 d. Itis contemplated, however, that the distal end of the adaptor couldcomprise a female lure-lock type connector (i.e., a hub including nubsor threads on its external surface) as well if required by a particularapplication.

In the illustrated embodiment, the fitting 220 has a generally tubularshape with a closed proximal end 222. The closed end 222 includes anaperture 224 of a sufficient size to receive a portion of the adaptorbody 25 d, as described below. The fitting 220 includes conventionalinternal threads 226 in order to engage corresponding threads of aconventional female lure-lock fitting (not shown).

The adaptor body 25 d desirably includes an annular groove 228 whichreceives a portion of the closed end 222 of the fitting 220 tointerconnect the fitting 220 and the adaptor body 25 d. Thisinterconnection also permits the fitting 220 to be rotated about theadaptor body 25 d.

To assemble the catheter adaptor 22 d, the conical shaped distal end 26d of the body 25 d is inserted into the aperture 224 of fitting closedend 222. The body 25 d is then forced into the fitting 220 to slightlydeflect the closed end 222 until the closed end 222 snaps into theannular groove 228 of the body 25 d. In this position, the body 25 dcaptures a portion of the fitting 220 to couple these elements together.

With reference to FIG. 11, the adaptor 22 c includes at least oneannular collar 200 interposed between the proximal and distal ends 28 c,26 c of the tubular body 25 c. The adaptor 22 d of FIG. 14 also includesa like annular collar 200 d. It is contemplated that the collar 200 ofthe adaptor 22 c of FIG. 11 and the collar 200 d of the adaptor 22 d ofFIG. 14 will be substantially identical, and, thus, the descriptionherein will be understood as applying equally to both embodiments.

The annular collar 200 flares radially outwardly and circumscribes thetubular body 25 c. The annular collar 200 has a thickness measured in alongitudinal direction which is slightly less than a width of a slot 50c in a retainer wall 46 c so that the collar 200 fits within the slot 50c of a retainer wall 46 c, as discussed in detail below.

The adaptor 22 c is preferably formed of a durable, biocompatibleplastic material. The adaptor 22 c more preferably is formed of clearplastic so a nurse can see bubbles or backflow through the adaptor 22 c.In an exemplary embodiment, the adaptor is formed of polycarbonate byinjection molded; however, those skilled in the art will readilyappreciate that the adaptor can be formed by other construction methodsknown in the art.

FIGS. 11 and 12 also illustrate the retainer 20 c which is substantiallyidentical to the retainer 20 described above. The retainer 20 ccomprises a central channel 44 c interposed between a pair of opposinglongitudinal walls 46 c. The central channel 44 c extends through theretainer 20 c along an axis which is generally parallel to alongitudinal axis of the retainer 20 c.

The central channel axis 44 c has a generally circular cross-sectionalshape which is truncated at an upper end to form an opening 47 c. Thecentral body 44 c has a diameter sized to receive the tubular body 25 cof the catheter adaptor 22 c. In a preferred embodiment, the diameter ofthe central channel 44 c generally matches that of the tubular body 25c.

In cross section, the central channel 44 c extends through an arcgreater than 180N about the channel axis such that the lateral length ofthe opening 47 c is less than the diameter of the central channel 44 c.In an exemplary embodiment, the cross-sectional shape of the centralchannel 44 c extends through an arc of about 200N about the channelaxis.

As best seen in FIG. 13 a, the channel axis is desirably skewed relativeto a base surface 48 c of the retainer 20 c. An incident angle θ formedbetween the base surface 48 c and the channel axis is less than 45N. Theincident angle θ desirably ranges between 5N and 30N. In an exemplaryembodiment for intravenous use, the angle θ preferably approximatelyequals 7N.

The longitudinal walls 46 c are substantially identical. Each wall 46 chas a thickness measured in the lateral direction less than the lengthof the support arm 32 of the adaptor 22, as it is desirable for thepresent retainer 20 c to accept both the above-described adaptor 22which comprises a support arm 32 connected to a clip 34, as well as thepresent adaptor 22 c which comprises an annular collar 200. Preferably,the thickness of the wall 46 c measured in the lateral direction isgreater than the distance measured radially by which the collar 200extends beyond the exterior surface of the tubular body 25 c (i.e., aradial height). The length of each wall 46 c, as measured in thelongitudinal direction, is preferably coextensive with the length of theretainer 20 c.

Each wall 46 c comprises a uniform series of slot 50 c. The seriescomprises at least two (2) slots 50 c and not more than twenty (20)slots 50 c. More preferably, the series comprises less than seven (7)slots 50 c. In an exemplary embodiment, as illustrated in the figures,the series comprises four (4) slots 50 c.

As discussed above, each slot 50 c is sized to receive the collar 200 ofthe adaptor 22 c, as well as the support arm 32 of the catheter adaptor22, to prevent longitudinal displacement of the respective adaptor 22,22 c. Each slot 50 c desirably has a rectangular shape. As seen in FIG.12, the slots 50 c extend from an exterior surface 52 c, through thewall 46 c, and open into the central channel 44 c. The width of the slot50 c, as measured in the longitudinal direction, is desirably slightlygreater than the width of the support arm 32 and the width of the collar200.

As illustrated by FIG. 13 a, each slot 50 c extends in the transversedirection from an upper edge 54 c of the longitudinal wall 46 c to apoint below the bottom 56 c of the central channel 44 c. The height ofthe slot 50 c, as measured in the transverse direction, is thus greaterthan the distance between the upper edge 54 c and the channel bottom 56c of the retainer 20 c. As seen in FIG. 13 b, the retainer 20 c furtherincludes a series of lateral grooves 202 which extend between opposingslots 50 c and extend into the retainer 20 c from the channel bottomsurface 56 c. The opposing slots 50 c and groove 202 thus form a lateralchannel which extends through the retainer 20 c in the lateral directionand cuts into the retainer 20 c from the upper edge 54 c to a pointbelow the channel bottom surface 56 c. The groove 202 desirably is sizedto receive a portion of the collar 200 such that with the tubular body25 c positioned within the central channel 44 c, the collar 200 extendsbetween opposing slots 50 c and into the groove 202. Thus, the groove202 has a depth, measured between the lower surface 56 c of the centralchannel 44 c and the bottom of the groove in transverse direction, whichis greater than the radial height of the annular collar 200.

FIG. 13 b illustrates that the spacing S between the slots 50 c, oncenter, desirably equals about half the distal L (see FIG. 2) betweenthe support arm 32 and the protuberance 40 of the catheter adaptor 22.The position of the slots in relation to the proximal and distal ends 26c, 28 c of the retainer 20 c is desirably configured in accordance withthe spacing and positioning discussed above in connection with theabove-described retainer 22, such that the present retainer 22 c can beused with the above-described adaptor 22, including a clip 34.

FIGS. 11 and 13 a illustrate the upper edge of each longitudinal wall 46c which comprises a series of chamfers 58 c formed and positioned asdisclosed above in connection with the retainer 20. As discussed above,the chamfers 58 c slope downwardly towards the slot 50 c to facilitatethe insertion of either the support arm 32 of the above-describedcatheter adaptor 22 or the annular collar 200 of the present catheteradaptor 22 c into the slot 50 c.

As FIGS. 11-13 b illustrate, each longitudinal wall 46 c may furthercomprise a relief 60 c disposed on the proximal end of the retainer 20c. The configuration and position of the relief 60 c desirably is inaccordance with the above description of the retainer 20. FIG. 11further illustrates that the retainer 20 c may additionally comprise akey-way groove 62 c to facilitate removal of the catheter adaptor 22 cfrom the retainer 20 c, as discussed above. The key-way groove 62 cdesirably is also positioned and configured in accordance with the abovedisclosure in connection with the retainer 20.

The retainer 20 c is made of relatively stiff plastic material, but issomewhat flexible such that the adaptor 22 c forces the upper edges 54 cof the longitudinal walls 46 c outwardly when a nurse presses theadaptor 22 c into the central channel 44 c of the retainer 20 c. Theretainer 20 c is desirably formed of polycarbonate by injection molding.When the adaptor 22 c sits within the central channel 44 c, the upperedges 54 c of the walls 46 c snap inwardly to their original position tosecurely hold the adaptor 22 c within the retainer 20 c.

An adhesive preferably attaches the retainer 20 c to the anchor pad 16c. Alternatively, the retainer 20 c may be attached to the anchor pad 16c by like means as well, e.g., embedding or otherwise weaving theretainer into the anchor pad 16 c.

FIG. 11 illustrates the anchor pad 16 c as comprising a flexible,laminate structure comprising an upper paper or other woven or non-wovencloth layer 64 c and a bottom adhesive layer 18 c, with an innercellulose foam layer 66 c interposed therebetween. Alternatively, theflexible base pad 16 may comprise an adhesive bottom layer 18 and anupper cellulose foam layer. An upper surface of the foam layer isroughened by corona treating with a low electric charge, as known in theart. The foam layer 66 c forms a cushion between the patient's skin andthe rigid, plastic retainer 20 c and tube clamp 24 c. The adhesive layer18 c may comprise a coating of diaphoretic or nondiaphoretic material,depending upon the patient's skin condition. A medical grade foam tapewith a diaphoretic or a nondiaphoretic adhesive is availablecommercially from NDM Manufacturers.

The removable paper or plastic backing (not shown) desirably covers thebottom adhesive layer 18 before use. As discussed above and illustratedin FIG. 12, the backing is preferably divided into a plurality of pieceand includes tabs 67 c to ease removal of the backing from the pad 16.The tabs 67 c may include indicia 69 c (e.g., dots, text, arrows, etc.)to indicate the location at which to grip the corresponding tab 67 cwhen peeling the removable backing off the pad 16 c.

As best seen in FIG. 12, the anchor pad 16 desirably has a generallytrapezoidal shape with rounded corners. A distal edge 206 of the anchorpad 16 c desirably has a width, as measured in the lateral direction,wider than that of a proximal edge 204. The longer distal edge 206provides a longer adhesive surface over a rough contact surface, suchas, for example, over knuckles, vertebrae, or the like. The generallytrapezoidal shape, however, minimizes the overall size of the anchor pad16 c attached to the patient. The trapezoidal shape also provides thesame surface area as a square pad with a appearance of a smaller pad.The longitudinal sides 208 of the anchor pad 16 c preferably taper fromthe proximal edge 206 to the distal edge 204, and more desirably haveconcave shapes.

The anchor pad includes a notch 68 c positioned along the proximal edge204 of the anchor pad 16 c and adjacent to the point of insertion of thecatheter cannula. Preferably, the notch 68 c is symmetrically positionedabout the channel axis 44 c of the retainer 20 c attached to the anchorpad 16 c. The notch 68 c is sized to permit visual inspection of thecatheterized site and is large enough to allow for variable placement ofthe pad 16 c with respect to the insertion site. That is, the notch 68 cis large enough that a nurse is not required to precisely position thepad on the patient's skin with respect to the indwelling catheter 14 c(not shown).

As seen in FIGS. 11 and 12, the anchor pad 16 c desirably may compriseindicia 70 c sometimes in the form of an arrow which indicates theproper orientation of the anchor pad 16 in reference to the catheterizedsite. When properly used, the indicia 70 c points toward the indwellingcatheter 14 c (not shown).

The anchor pad 16 c preferably supports a clip 24 c which secures thefluid supply tube 12 c to the anchor pad 16 c. As seen in FIG. 12, thefluid supply tube 12 c is preferably looped back around in a proximaldirection and inserted into the clip 24 c to form a safety loop, asknown in the art. The tube clip 24 c is desirably configured inaccordance with the above description. The clip 24 c may be made in avariety of sizes to accommodate various calibers of fluid flow tubing 12c.

In use, a nurse typically uses the catheter anchoring system 10 c inconnection with an indwelling catheter 14 c (not shown). The catheter 14c is inserted into a body lumen, such as a vein, in accordance with theabove description. The nurse then inserts the distal end 26 c of theadaptor 22 c into a catheter hub 30 c (not shown) to connect the adaptor22 c to the catheter 14 c. The nurse may then secure the adapter 22 c tothe catheter 14 c by means of the ratchet clip, or the lure-lockfitting.

The nurse removes the paper backing which initially covers the adhesivebottom surface 18 c of the anchor pad 16 c, as described above, andattaches the anchor pad 16 c to the patient's skin proximate to theindwelling catheter 14 c. The nurse specifically positions the notch 68c of the pad 16 c around the catheter cannula 14 c with the indicatingarrow 70 c pointing in the direction of the catheter 14 c. The nursegenerally aligns the proximal edge 204 of the anchor pad 16 c with theinsertion site.

The nurse positions the adaptor 22 c above the series of retainer slots50 c, and snaps the adaptor 22 c into the retainer 20 c. In doing so,the adaptor 22 c is pressed between the longitudinal walls 46 c of theretainer 20 c with the annular collar 200 extending into opposing slots50 c and into the corresponding groove 202 of the retainer 20 c. As thenurse presses the adaptor into the retainer 20 c, the chamfered edges 58c around the slots 50 c of the longitudinal walls 46 c guide the annularcollar 200 into the slots 50 c. The retainer 20 c secures the adaptor 20c as described above.

With the annular collar 200 positioned in the opposing slots 50 c theadaptor 22 c is prevented from sliding in a longitudinal direction.

Like the above-described embodiments of the retainer, the ergonomicdesign of the retainer 20 c provides for various positions of theadaptor 22 c in the retainer 20 c so that the retainer 22 c is nottechnique- or position-sensitive. That is, a nurse can simply press theadaptor 22 c into the retainer 20 c, irrespective of the position of theannular collar 20 relative to a particular slot 50 c of the retainer 20c. So long as the annular collar 200 is positioned above the series ofslots 50 c, the chamfered edges 58 c of the wall 46 c will guide theannular collar 200 into the slot 50 c.

The present embodiment of the retainer 20 c, as mentioned above, mayalso be used with the above-described adaptor 22 having the clip 34. Anurse uses the present retainer with the above-described adaptor 22 inthe same manner as described above in connection with theabove-described retainer 20.

If the catheter hub 30 (see FIG. 1) is a standard female lure-lockfitting, the lure-lock fitting 220 (FIG. 14) of the adaptor body 22 d isrotated with the distal end 26 d inserted into the catheter hub 30 tointerlock the corresponding fittings 222, 30 in the known manner. Thecatheter adaptor 22 d is then used with the anchoring system in a likemanner to that described above.

The above embodiments illustrate the adaptor with the radially extendingmember being affixed to an end of a tube set or other fluid line. Theradially extending member can also be arranged on the adaptor or fittingthat is affixed to the proximal end of the catheter body. FIGS. 15 athrough 15 c illustrate this arrangement.

FIGS. 15 a through 15 c illustrate a catheterization system configuredin accordance with another embodiment of the present invention. Thecatheterization system includes a catheter and an anchoring system thatincludes a retainer and an anchoring pad. Although the anchoring pad hasbeen omitted from FIGS. 15 a through 15 c to simplify the drawings, theanchor pad desirably is constructed in accordance with the abovedescription and is shaped in the form shown in FIG. 16. Again, forconsistency, like numbers with an “e” suffix have been used to indicatelike parts of the anchoring system of FIGS. 11 and of 15 a-15 c. Theabove description of like components thus should be understood asapplying equally to the present embodiment, unless stated otherwise.

The catheter desirably includes an elongated tubular body with a tubularadaptor or fitting attached to the body. At least one lumen of theadaptor communicates with a corresponding lumen of the catheter. In theillustrated embodiment, the adaptor 22 e is permanently attached to aproximal end of the fitting and is configured to cooperate with acorresponding adaptor formed on a distal end of a fluid line. Theadaptor 22 e, however, can be releasably attached to the catheter body.

In the illustrated embodiment, the tubular adaptor 22 e is configured asa female-component of the coupling between the catheter body and thefluid line. The adaptor 22 e of course can be configured as the malecomponent of the coupling. In either case, both the male and femaleadaptors of the coupling have corresponding generally frusto-conicalshapes which mate together in a generally fluid tight engagement. Thecoupling adaptors also include interengaging elements that lock togetherthe adaptors. The tubular adaptor 22 e of the illustrated embodimentincludes a threaded coupler 306 formed by an external thread that runsabout a proximal end 300 of a tubular body of the adaptor 22 e. Theexternal thread of the threaded coupler is configured to correspondingto an internal thread of a spin nut disposed on the end of thecorresponding adaptor (such as the type illustrated in FIG. 14).

In the illustrated embodiment, the tubular body of the adaptor 22 eincludes a frusto-conical shaped section 304 on the distal side 302 ofthe threaded coupler 306. The corresponding form of the adaptor 22 egenerally corresponds to a conventional catheter hub, such as the typeillustrated in FIG. 1.

Unlike a conventional catheter hub, however, the adaptor 22 e includes aradially extending member that projects from the tubular body. In theillustrated embodiment, the radially extending member comprises anannular collar 200 e that circumscribes a portion of the frusto-conicalshaped section 304 of the tubular body. The collar 200 e is generallypositioned about midway between the proximal and distal ends 300, 302 ofthe tubular body; however, it need not be as illustrated in embodimentof FIG. 16.

As understood from FIGS. 15 a through 15 c, the retainer 20 e defines acentral channel 44 e that has a generally conical shape corresponding tothe shape of the adaptor tubular body. The channel 44 e is interposedbetween a pair of opposing converging longitudinal walls 46 e.

The walls 46 e are spaced apart such that there is a variable lateraldistance therebetween. The walls 46 e have a proximal end 300 and adistal end 302, with the proximal end width being desirably wider thanthe distal end width.

The central channel 44 e extends through the retainer 20 e along thelongitudinal axis and between the converging walls 46 e. The channel 44e is similarly of variable lateral dimension as taken at points alongthe longitudinal axis direction.

The central channel 44 e has a truncated upper section which gives thechannel a generally U-shape having an upper opening 47 e. The bottom andside surfaces of the channel 44 e are arcuate and substantially matchthe shape of the catheter adaptor 22 e, which can be received therein.The variable diameter of the channel 44 e is sized to receive thelongitudinal length of the catheter adaptor 22 e. Each section of thechannel 44 e has arcuate shape of a radius of curvature that generallymatches a corresponding section of the catheter adaptor 22 e. In theillustrated embodiment, the radii of curvature vary along thelongitudinal length of the channel 44 e; however, the channel 44 e canhave generally uniform radii of curvature, as illustrated by the aboveembodiments.

In cross section, as best understood from FIG. 15 c, the channel 44 eextends through an arc of greater than 180° about the longitudinal axissuch that the lateral length of the upper opening 47 e is less than thediameter of the channel 44 e at a given point in the longitudinaldirection. In the illustrated embodiment, the channel 44 e desirablyextends through an arc of about 200° about the channel axis.

The retainer also includes at least one slot 50 e that lies generallyperpendicular to the longitudinal axis and extends across the channel 44e to section the channel 44 e into a proximal channel portion and adistal channel portion. In the illustrated embodiment, the proximal anddistal channel portions have generally equal longitudinal lengths;however, they need not have the same length. The length of the channelportions though desirably provides stability to the catheter adaptor 22e when inserted into the retainer 20 e to prevent the catheter adaptor22 e from yawing (i.e. pivoting relative to the retainer within a planeparallel to the anchor pad). Each channel section of the retainer 20 eis also sized to receive a corresponding section of the catheter adaptor22 e. Each slot 50 e is sized to receive the collar 200 e of thecatheter adaptor 22 e.

The slot 50 e has a thickness that substantially matches the thicknessof the adaptor collar 200 e. The thickness of slot 50 e, however, isless than the combined longitudinal lengths of the proximal and distalchannel portions. This dimensional relationship provides furtherstability to the retained catheter adaptor 22 e when inserted into theretainer 20 e.

In the illustrated embodiment, the retainer 20 e includes at least twolateral slots 50 e arranged in series (i.e., next to each other) betweenthe proximal and distal channel portions. The series of slots desirablyincludes between two (2) and twenty (20) slots. More preferably, theseries comprises less than seven (7) slots. The illustrated embodimentshows two (2) slots.

As described above, each slot 50 e is sized to receive a portion of theadaptor annular collar 200 c to prevent longitudinal displacement of thecatheter, as discussed in detail above. Each slot 50 e desirably has arectangular shape and extends from an exterior surfaces 52 e through thewalls 46 e, and across the central channel 46 e. The width of each slot50 e (measured longitudinally) is desirably slightly greater than thewidth of the fitting 304, measured in the longitudinal direction toreceive the fitting 304, as discussed above.

The retainer 20 e also desirably includes a relief 308 formed on thebottom of the channel 44 e. The relief 308 is sized to receive a portionof the collar 200 e when placed within one of the slots 50 e.

Finger platforms 310 extend from the side walls 46 e of the retainer 20e. The finger platforms 310 are sized and configured to enable allow ahealth care provider to press the retainer 20 e against the skin of thepatient while pulling up on the catheter adaptor 22 e or on the adaptorto which it is connected, when disengaging the catheter adaptor 22 efrom the retainer 20 e.

So configured, in addition to the interengagement between the slots 50 eand annular collar 200 e, longitudinal movement of the catheter in theproximal-to-distal direction is further inhibited by cooperation betweenthe conical-shaped channel 44 e and frusto-conical shaped fitting 304.That is, when an applied force directs the fitting 304 in the distaldirection, the fitting 304 advances until contact with a section of thewalls 46 e (which are of uniformly narrower diameter as measured towardthe proximal end of the walls 46 e). When contact is made, the fitting304, and catheter which is attached thereto, is restricted from furtherdistal movement.

FIG. 16 illustrates another embodiment of the catheterization systemsimilar to that described above in connection with FIGS. 15 a-15 c.Accordingly, like reference numerals with a “f” suffix have been used toindicate similar components between these embodiments. The abovedescription of like components thus applies equally to the presentembodiment, unless stated otherwise.

In the illustrated embodiment, the conical shaped section of thecatheter hub 304 has an irregular step in diameter between the sideproximal 300 f of the collar 200 f and the side distal 302 f of thecollar 200 f. That is a minimum diameter of the conical section on theside proximal 300 f the collar 200 f is larger than a maximum diameterof the conical section on the side distal 302 f of the collar 200 f.

The retainer 20 f has a shape corresponding to that of the conicalsection of the catheter adaptor 22 f. The proximal 300 f channel portionhas a radius of curvature generally matching that of the proximal 300 fside of the adaptor conical section. And the distal 302 f channelportion has a radius of curvature generally matching that of the distal302 f side of the adaptor conical section. As such, a minimum diameterof the proximal 300 f channel section is larger than a maximum diameterof the distal 302 f channel section.

The retainer 20 f is mounted atop an anchor pad 16 f with its upperopening 47 f being exposed and facing away from the anchor pad 16 f. Theconstruction of the anchor pad 16 f and the retainer 20 f, as well asthe attachment of the retainer 20 f to the anchor pad 16 f, are inaccordance with the above description. The anchor pad 16 f also supportsa tube clip 24 f, as illustrated in FIG. 16.

As similar to the above embodiment, the present catheterization systemis used by first connecting the catheter to a fluid line (be it supplyor drainage). The catheter is inserted into a body lumen, such as avein, in accordance with the above description. The nurse then inserts adistal end of one of the coupling adaptor 22 c into a catheter adaptorto connect together the adaptors. The nurse may then interconnect theadapters by means of the above-described ratchet clip, or the lure-lockfitting formed between the threaded coupler on the proximal end of thecatheter adaptor and the spin nut on the end of the adaptor attached tothe fluid tube.

The nurse removes the paper backing which initially covers an adhesivebottom surface of the anchor pad 16 f, as described above, and attachesthe anchor pad 16 f to the patient's skin proximate to the indwellingcatheter. The nurse specifically positions a notch of the pad 16 faround the catheter body or cannula. The nurse generally aligns theproximal edge of the anchor pad 16 f with the insertion site.

The nurse positions the adaptor 22 f above the series of retainer slots50 f, and snaps the adaptor 22 f into the retainer 20 f. In doing so,the adaptor 20 f is pressed between the longitudinal walls 46 f of theretainer 20 f with the annular collar 200 f extending into one of theslots 50 f of the retainer 20 f. As the nurse presses the adaptor 22 finto the retainer 20 f, chamfered edges 312 around the slots 50 f (seeFIG. 15 a) of the longitudinal walls 46 f guide the annular collar 200 finto the slots 50 f. With the annular collar 200 f positioned in one ofthe slots 50 f; the adaptor 22 f is prevented from sliding in alongitudinal direction.

Like the above-described embodiments of the retainer 20 f, the ergonomicdesign of the retainer 20 f provides for various positions of theadaptor 22 f in the retainer 20 f so that the retainer 20 f is nottechnique- or position-sensitive. That is, a nurse can simply press theadaptor 22 f into the retainer 20 f, irrespective of the position of theannular collar 200 f relative to a particular slot 50 f of the retainer20 f. So long as the annular collar 200 f is positioned above the seriesof slots 50 f, the chamfered edges 312 of the wall will guide theannular collar 200 f into the slot 50 f.

FIGS. 17 and 18 illustrate a catheterization system configured inaccordance with another embodiment of the present invention. Like theother embodiments of the catheterization system, this embodimentincludes a catheter and an anchoring system that includes a retainer andan anchoring pad. Again, for consistency, like numbers with an “g”suffix have been used to indicate like parts of the anchoring system ofFIGS. 11 and of 16. The above description of like components thus shouldbe understood as applying equally to this embodiment, unless statedotherwise.

The present embodiment, like the previous embodiments, utilizes theconcept of providing an adaptor and retainer which cooperate with eachother to secure the catheter to the body of a patient and inhibitmovement of the catheter in the longitudinal, transverse and lateraldirections. Also, like the previous embodiments, the anchoring systemcan include the concept of not being position or technique sensitive.That is, the medical attendant can simply locate the catheter adaptorgenerally above the retainer and press the adaptor into the retainer.Engagement thus requires only coarse alignment of the adaptor with theretainer.

FIG. 17 shows the retainer 20 g comprising a longitudinal channel 44 gformed between a pair of substantially parallel walls 46 g andconfigured to receive the tubular body of the adaptor 22 g in a snap fitmanner. The construction of the channel thus is similar to thatdescribed above and about a longitudinal axis L.

The retainer 20 g additionally comprises at least one projection orprotuberance 400 that extends from one of the walls 46 g toward thelongitudinal axis in the lateral direction. The projection 400 is sizedand configured to cooperate with a recess on the catheter adaptor 22 g,as explained below. The projection 400, however, can extend into thechannel 44 g toward the longitudinal axis in the transverse direction.

In the illustrated embodiment, the retainer 20 g includes a plurality ofprojections 400. In one mode, two projections are positioned across fromeach other on opposite walls 46 g. The set of projections 400 thusoppose each other. The retainer 20 g also desirably includes a pluralityof projection sets 400 which are spaced along a length of the channel 44g. The multiple projection sets 400 thus provide multiple positions inwhich the adaptor 22 g can occupy within the retainer 20 g, so as torequire only coarse alignment between the retainer 20 g and the adaptor22 g before engagement. Both laterally and transversely extendingprojections 400 can be used with the retainer.

The projections 400 desirably are positioned between a first portion ofthe channel 44 g and a second portion of the channel 44 g. In theillustrated embodiment, one channel portion is formed at a proximal endof the channel 44 g and the other end is formed at a distal end of thechannel 44 g. Each of the channel portions desirably are sufficientlylong and support a sufficient length of the adaptor 22 g so as toprevent the adaptor 22 g from rocking.

Each projection 400 desirably has sufficient thickness or bulk so as toresist nominal applied forces, i.e. not break when the medical attendantpresses on it. Also, the portion of the projection 400 that projectsinto the channel 44 g is of sufficient lateral or transverse dimensionto inhibit movement of the catheter adaptor 22 g in the longitudinaldirection, without inhibiting placement of the catheter adaptor 22 ginto or out of the channel 44 g. That is, the projections 400 extendinto the channel by a sufficient amount to engage with correspondingstructure on the catheter adaptor 22 g, as described below.

In the illustrated embodiment, each projection 400 has generally arectangular shape in a plane generally parallel to the retainer base 48g. Thus, the projections 400 generally form a series of square teethalong a section of each wall 46 g at an upper rim of the channel 44 g.The projection 400, however, can be configured in a wide variety ofother shapes, including, but not limited to, semi-circular, square,curvilinear, triangular or the like. Thus, the projection 400 may belinear, as illustrated, or curved or curvilinear to suit a particularapplication, so as to inhibit migration of the catheter adaptor 22 g inthe longitudinal direction.

Below the upper rim of the channel 44 g, each projection tapers backtoward the corresponding side wall 46 g. In the illustrated embodiment,this taper 406 generally follows an arcuate path that desirablycorresponds to a surface to the adaptor 22 g, as described below. Theprojections 400, however, can extend about the entire arc of the channel44 g (i.e., down one side wall, across the bottom of the channel and upthe other side wall) or the projections 400 can extend downward to thechannel bottom (FIG. 18).

As noted above, the projections 400 are advantageously sized andconfigured to cooperate with a corresponding recess(es) on the catheteradaptor 22 g. Without limitation, the catheter adaptor 22 g can be afitting on the end of either the fluid tube, as shown in FIG. 17, or thecatheter as shown in FIG. 18 (e.g., a catheter hub).

In one mode, the projections 400 fit into the recess(es) and engage thesides of the recess(es) so as to inhibit longitudinal movement of theadaptor 22 g relative to the retainer 20 g. In the illustratedembodiment, the adaptor 22 g includes a plurality of annular grooves ordepressions 408 (e.g., three grooves); however, any number of annulargrooves 408 can be used with the adaptor 22 g. In order to accommodatethe adaptor 22 g in multiple positions within the retainer 20 g,however, the number of projection sets 400 should be less than thenumber of grooves 408.

Each annular groove 408 is interposed between the proximal and distalends 28 g, 26 g of the adaptor 22 g and extends radially inward whilecircumscribing the adaptor 22 g. Each annular groove 408 also has athickness measured in the longitudinal direction which is slightly lessthan the longitudinal length of the projection 400 so that at least aportion of the annular depression 408 fits around the projection 408 ofthe retainer wall 46 g, as described above.

Each annular groove 408 thus defines an arcuate surface on the exteriorof the adaptor 22 g. In the illustrated embodiment, the radius of thisarcuate surface desirably is not greater than the radius of curvaturefollowed by the corresponding projection(s) 400 as it tapers toward therespective wall 46 g, as noted above.

FIG. 18 is generally similar to FIG. 17 except that the retainer 20 g isconfigured to receive a frusto-conical shaped section 304 g of theadaptor 22 g, rather than an adaptor 22 g having a uniform diameter, asshown in FIG. 17. To form the snap fit engagement between the retainer20 g and tapered adaptor 22 g, the channel 44 g extends through theretainer 20 g along the longitudinal axis and between converging walls46 g, thus forming a tapered or stepped region. The illustratedembodiment also shows four projections 400 formed on the retainer 20 g,however, it is understood that any suitable number of projections (2-20)can be used with the retainer 20 g.

The present embodiment of the catheterization system is used by firstcatheter is inserted into a body lumen, such as a vein, in accordancewith the above description. The medical attendant then connects thecatheter adaptors together so as to attach the catheter to the fluidline. The medical attendant may then interconnect the adapters by meansof the above-described ratchet clip, or the lure-lock fitting formedbetween the threaded coupler on the proximal end of the catheter adaptorand the spin nut on the end of the adaptor attached to the fluid tube.

The medical attendant positions the adaptor 22 g above the series ofretainer projections 400, and snaps the adaptor 22 g into the retainer20 g. In doing so, the adaptor 22 g is pressed between the longitudinalwalls 46 g of the retainer 20 g with at least a portion of the annulardepression 408 receiving a corresponding projection 400. With at least aportion of the annular depression 408 positioned around one of theprojections 400, the adaptor 22 g is inhibited from moving in alongitudinal direction. The medical attendant then removes the paperbacking which initially covers an adhesive bottom surface of the anchorpad 16 g and attaches the anchor pad 16 g to the patient's skinproximate to the indwelling catheter, as described above.

As previously explained, the ergonomic design of the retainer 20 gprovides for various positions of the adaptor 22 g in the retainer 20 gso that the retainer 20 g is not technique or position sensitive. Thatis, a medical attendant can simply press the adaptor 22 g into theretainer 20 g, irrespective of the position of the annular depression408 relative to a particular projection 400 of the retainer 20 g.Further, so long as the annular depression 408 is positioned above theseries of projections 400, the chamfered edges 312 g of the wall 46 gwill guide the annular depression around at least a portion of theprojection 400.

Although this invention has been described in terms of certain preferredembodiments, other embodiments apparent to those of ordinary skill inthe art are also within the scope of this invention. It is alsounderstood that various aspects of one embodiments can between withanother embodiment. Accordingly, the scope of the invention is intendedto be defined only by the claims which follow.

1. A securement device for attaching a medical article to a patient, themedical article having a generally elongated body and a side member thatprojects away from the body, the securement device comprising: aretainer having a first channel portion and a second channel portion,the channel portions being disposed about a longitudinal axis of theretainer and having a length measured in a direction parallel to thelongitudinal axis of the retainer, the retainer directly contacting themedical article along at least a substantial portion of the longitudinallengths of the first and second channel portions, each channel portioncurving about the longitudinal axis of the retainer by greater than180°, the first channel portion being spaced from the second channelportion, at least part of the first channel portion being wider, asmeasured perpendicularly to the longitudinal axis of the retainer, thananother part of the first channel portion, the combined longitudinallengths of the first and second channel portions being larger than adistance separating the first and second channel portions along thelongitudinal axis of the retainer, said distance substantially equalinga dimension of the side member of the medical article as measuredparallel to the longitudinal axis of the retainer; a base, the retainerbeing coupled to the base so as to move in a longitudinal directionrelative to the base; and an interlocking mechanism, at least a portionof the interlocking mechanism being movable in a direction perpendicularto the longitudinal direction so as to limit the retainer from movingrelative to the base.
 2. A securement device according to claim 1,wherein at least one of the channel portions is exposed though alongitudinally extending opening.
 3. A securement device according toclaim 1, wherein each channel portion defines a longitudinally extendingopening.
 4. A securement device according to claim 3, wherein eachopening has a width less than a width of the corresponding channelportion.
 5. A securement device according to claim 1 further comprisinga flexible anchor having an adhesive bottom surface and a top surfaceabove which the retainer is disposed.
 6. A securement device accordingto claim 5, wherein each channel portion includes a longitudinal openingand the retainer is disposed in a position above the top surface so asto expose the openings to the channel portions.
 7. A securement deviceaccording to claim 5, wherein the longitudinal axis of the retainer isdisposed at an acute angle relative to the anchor.
 8. A securementdevice according to claim 1, wherein at least one of the first andsecond channel portions has a truncated generally circularcross-sectional shape.
 9. A securement device according to claim 1,wherein the cross-section of at least one of the first and secondchannel portions tapers in size along its length.
 10. A securementdevice according to claim 1, wherein at least one of the first andsecond channel portions has a generally frusto-conical shape.
 11. Asecurement device according to claim 1, wherein the distance separatingthe first and second channel portions forms a continuous gap whichextends around the longitudinal axis of the retainer for at least 180degrees.
 12. A securement device according to claim 1, wherein theretainer further comprises a pair of opposing surfaces from which thefirst and second channel portions extend in opposite directions alongthe longitudinal axis.
 13. A securement device according to claim 12,wherein the opposing surfaces are generally perpendicular to thelongitudinal axis.
 14. A securement device according to claim 1, whereinthe direct contact between the medical article and at least one of thefirst and second channel portions is discontinuous along thelongitudinal length of the at least one of the first and second channelportions.
 15. A securement device for attaching a medical article to apatient, the medical article having a generally elongated body and aside member that projects away from the body, the securement devicecomprising: an anchor pad; a base affixed to the anchor pad; and aretainer movably coupled to the base so as to move in a longitudinaldirection relative to the base, the retainer comprising at least firstand second channel portions arranged side-by-side along a longitudinalaxis of the retainer with at least one gap occurring between the channelportions, the gap having a dimension in a direction parallel to thelongitudinal axis of the retainer that generally matches a dimension ofthe side member of the medical article as measured parallel to thelongitudinal axis of the retainer; and an interlocking mechanism, atleast a portion of the interlocking mechanism being movable in adirection perpendicular to the longitudinal direction so as to limit theretainer from moving relative to the base.
 16. A securement deviceaccording to claim 15, wherein at least one of the channel portions isexposed though a longitudinally extending opening.
 17. A securementdevice according to claim 15, wherein each channel portion defines alongitudinally extending opening.
 18. A securement device according toclaim 17, wherein each opening has a width less than a width of thecorresponding channel portion, where said widths are measuredperpendicularly to the longitudinal axis of the retainer.
 19. Asecurement device according to claim 18, wherein the retainer isdisposed above the base and in a position that exposes the openings tothe channel portions.
 20. A securement device according to claim 15,wherein the anchor pad comprises an adhesive bottom surface and a topsurface above which the base is disposed.
 21. A securement deviceaccording to claim 20, wherein the longitudinal axis of the retainer isdisposed at an acute angle relative to the bottom surface of the anchorpad.
 22. A securement device according to claim 15, wherein thecross-section of at least one of the first and second channel portionstapers in size along its length.
 23. A securement device according toclaim 15, wherein at least one of the first and second channel portionshas a generally frusto-conical shape.
 24. A securement device accordingto claim 15, wherein said gap is defined by a pair of opposing surfaces.25. A securement device according to claim 24, wherein the opposingsurfaces lie generally perpendicularly to the longitudinal axis of theretainer.
 26. A securement device according to claim 15, wherein thedistance separating the first and second channel portions forms acontinuous gap which extends around the longitudinal axis of theretainer for at least 180 degrees.
 27. A securement device according toclaim 15, wherein at least one of the first and second channel portionsextends about the longitudinal axis of the retainer by greater thanabout 180°.
 28. A securement device according to claim 15, wherein thefirst channel portion of the retainer has a truncated circularcross-sectional shape and surrounds at least a portion of the medicalarticle through an arc of greater than 180 degrees about thelongitudinal axis of the first channel portion when the medical articleis received by the first channel portion.
 29. A securement deviceaccording to claim 15, wherein at least part of the first channelportion is wider, as measured perpendicularly to the longitudinal axisof the retainer, than the second channel portion.
 30. A securementdevice for attaching a medical article to a patient, the medical articlehaving a generally elongated body and a side member that projects awayfrom the body, the securement device comprising: a retainer includingfirst and second channel portions that each curve about a longitudinalaxis of the retainer by more than 180°, the retainer directly contactingthe medical article along at least a substantial portion of thelongitudinal lengths of the first and second channel portions, eachchannel portion having an opening that extends along the longitudinalaxis of the retainer, the first and second channel portions beingdisposed apart with at least one gap therebetween, a distance across thegap as measured in a direction parallel to the longitudinal axis of theretainer being substantially the same as a dimension of the side memberof the medical article, which is measured along the longitudinal axis ofthe retainer, and being less than the combined lengths of the first andsecond channel portions as measured parallel to the longitudinal axis ofthe retainer; a base, the retainer being coupled to the base so as tomove in a longitudinal direction relative to the base; an interlockingmechanism, at least a portion of the interlocking mechanism beingmovable in a direction perpendicular to the longitudinal direction so asto limit the retainer from moving relative to the base; and a flexibleanchor having a bottom surface with an adhesive for attaching the anchorto the patient, the base being coupled to the anchor.
 31. A securementdevice according to claim 30, wherein at least one of the first andsecond channel portions has a truncated circular cross-sectional shape.32. A securement device according to claim 30, wherein the cross-sectionof at least one of the first and second channel portions tapers in sizealong its length.
 33. A securement device according to claim 30, whereinat least one of the first and second channel portions has a generallyfrusto-conical shape.
 34. A securement device according to claim 30,wherein said gap is defined by a pair of opposing surfaces.
 35. Asecurement device according to claim 34, wherein the opposing surfacesgenerally lie perpendicular to the longitudinal axis of the retainer.36. A securement device according to claim 30, wherein the directcontact between the medical article and at least one of the first andsecond channel portions is discontinuous along the longitudinal lengthof the at least one of the first and second channel portions.